Catheters are tube like devices which are inserted into a portion of a person's body in order to transport fluids, such as liquids, gases, and sometimes semisolids, in or out of that particular portion of the body. For instances, urinary catheters are used to transport urine collected in the bladder out of the body via the urinary tract. Other types of catheters such as gastronomy devices, transport fluids into and out of various segments of the gastrointestinal system, primarily the stomach.
In order to provide a means of retaining the catheter within the body, inflatable bag catheters were introduced many years ago. Subsequently, Foley (U.S. Pat. No. 3,409,016) taught an elongated catheter having a secondary lumen for inflating a retention balloon at a distal end of the catheter once the distal end is positioned within the body. Such catheters are now generally referred to as "Foley" catheters out of respect for the contribution made by Dr. Foley.
Improvements on Dr. Foley's contribution to the catheter art continue to find their way into the market place today. In spite of the many practical uses for these devices today, they do have limitations, a few of which are discussed below. First, they are difficult for untrained individuals to use, especially relatively untrained nursing home attendants and/or patient's who may wish to care for their own needs. Second, because the fluid to expand the balloon is delivered from an external source, it is possible to burst the balloon by injecting too much fluid. It will be appreciated that this creates a safety concern. Third, it is possible that the secondary lumen which communicates with the cavity of the expandable balloon may become clogged during use of the catheter, thereby creating a problem when it becomes time to deflate the expandable balloon and remove the catheter. Fourth, the outer surface of the catheter leading to the balloon can irritate internal surfaces of the body with which it comes into contact, thereby creating inflamed areas which can be painful to the patient and may be more susceptible to bacterial infection. Fifth, the conduit portion of the catheter immediately adjacent to the expandable balloon does not fully engage or conform to the internal surfaces of the body approximate the expandable balloon. In the case of a urinary catheter, this often enables urinary fluids from the bladder to pass through the sphincter at the proximal end of the urinary passageway, thereby allowing urinary fluids to leak out of the bladder into the urinary passageway, thereby creating a risk of infection for the catheterized patient. Sixth, the cost of manufacturing traditional Foley catheters has been influenced by the need to use a significant amount of hand labor to make the devices. It will be appreciated that efforts to reduce the amount of hand labor in the manufacture of such devices may reduce the cost of such devices so that they are more competitive in the market place.
It will be appreciated, therefore, that there is a need for a retention catheter, as well as methods for making and using the same, which will address these and other problems associated with prior art devices and methods. The present invention provides advantages over the prior art catheters, over the prior art methods for manufacturing and using the same, and also offers other advantages over the prior art and solves other problems associated therewith.